Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Costotransverse foramen block, Erector spinae plane block.
- Who it may be relevant to
- Registry conditions: Costotransverse Foramen Block, Erector Spinae Plane Block, Modified Radical Mastectomy. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial
Overview
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.
Detailed description
Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.
Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.
A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles
Interventions
- Other Costotransverse foramen block
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%. - Other Erector spinae plane block
Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
Primary outcome measures
- Total morphine consumption [Time frame: 24 hours postoperatively]
Secondary outcome measures (6)
- Degree of pain [Time frame: 48 hours postoperatively]
- Time to first request of rescue analgesia [Time frame: 24 hours postoperatively]
- Intraoperative fentanyl consumption [Time frame: Intraoperatively]
- Mean arterial pressure [Time frame: 4 hours postoperatively]
- Heart rate [Time frame: 4 hours postoperatively]
- Incidence of adverse effects [Time frame: 24 hours postoperatively]
Eligibility criteria
Inclusion criteria
- Adult females > 18 years and ≤ 65 years old.
- American Society of Anesthesiologists (ASA) physical status П-III.
- Body mass index (BMI) 18-35 kg/m2.
- Scheduled for modified radical mastectomy.
Exclusion criteria
- Known allergy or hypersensitivity to local anesthetic agents.
- Active infection at the injection site (e.g., cellulitis, abscess).
- Coagulopathy or ongoing anticoagulant/antiplatelet therapy \[International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL\].
- Severe respiratory, cardiac, hepatic, or renal disease.
- Morbid obesity.
- Severe cognitive impairment or uncooperative behavior that could interfere with block placement.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Cairo University — Cairo
Identifiers
NCT: NCT07367568 · AP2509-501-124-203